BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 1923497 · Received December 13, 2010

    Report

    Report Number
    1058196-2010-00376
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING REPOSITIONING OF THE ORBIT RDFL COMPLEX MINI COIL, THE COIL STRETCHED. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS TREATMENT OF A SACCULAR ANEURYSM IN A NORMAL DISTAL INTERNAL CAROTID ARTERY. THE ANEURYSM MEASURED 4.5X3.9MM WITH A 1.5MM NECK. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (MC) AT ALL TIMES. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MC, AND THERE WERE NO KINKS THAT MAY HAVE CONTRIBUTED TO THE EVENT. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MC, THE Y-CONNECTOR WAD LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. NO FURTHER INFORMATION PERTAINING TO THE PROCEDURAL USE OR THE REPORTED EVENT IS AVAILABLE. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED SEPARATED FROM THE DEVICE. THE SUPPORT COIL AND GRIPPER WERE INSPECTED AND NO DAMAGES WERE FOUND ON THEM. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS FOUND STRETCHED. THE EMBOLIC COIL AND THE GRIPPER WERE INSPECTED UNDER MICROSCOPE. THE EMBOLIC COIL WAS FOUND STRETCHED AND THE GRIPPER WAS NOT DAMAGED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED STRETCHED COIL WAS CONFIRMED; HOWEVER, THE CAUSE OF THE KINKS ON THE HYPOTUBE AND ALSO THE STRETCHED EMBOLIC COIL COULD NOT BE CONCLUSIVE DETERMINED. INSPECTIONS ARE IN PLACE TO PREVENT THESE TYPES OF DAMAGES LEAVING FROM THE FACILITY. BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE ANALYSIS AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THE ROOT CAUSE AND POSSIBLE CONTRIBUTING FACTORS CANNOT BE DETERMINED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED COILED INSIDE OF PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. THE INTRODUCER WAS RECEIVED SEPARATED OF THE DEVICE. THE SUPPORT COIL AND GRIPPER WERE INSPECTED AND NO DAMAGES WERE FOUND ON THEM. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER AND IT WAS FOUND STRETCHED. THE EMBOLIC COIL AND THE GRIPPER WERE INSPECTED UNDER MICROSCOPE. THE EMBOLIC COIL WAS FOUND STRETCHED AND THE GRIPPER WAS NOT DAMAGED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE REPORTED BY THE COSTUMER AS "COIL -UNRAVELED/STRETCHED" WAS CONFIRMED. THE CAUSE OF THE KINKS ON HYPOTUBE AND ALSO THE STRETCHED EMBOLIC COIL COULD NOT BE CONCLUSIVE DETERMINATE; HOWEVER, NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THESE DAMAGES COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. HOWEVER THE CAUSE IS INCONCLUSIVELY AND UNDETERMINED; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING REPOSITIONING OF THE ORBIT RDFL COMPLEX MINI COIL, THE COIL STRETCHED. THERE WAS NO PATIENT INJURY REPORTED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE (MC) MICROCATHETER AT ALL TIMES. THERE WAS NO RESISTANCE WHEN THE COIL WAS INSERTED IN THE MICROCATHETER, AND THERE WERE NO KINKS THAT MAY HAVE CONTRIBUTED TO THE EVENT. A BALLOON OR STENT REMODELING PRODUCT WAS NOT USED DURING THE PROCEDURE. AFTER THE DELIVERY SYSTEM WAS LOADED INTO THE MICROCATHETER, THE Y-CONNECTOR WAD LOCKED TO SECURE THE DELIVERY SYSTEM, AND NO DAMAGES WERE NOTICED ON THE DELIVERY SYSTEM AFTER THE Y CONNECTOR WAS CLOSED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE TARGET SITE WAS A NORMAL DISTAL (ICA) INTERNAL CAROTID ARTERY, AND SACCULAR ANEURYSM, MEASURING 4.5X3.9MM, NECK 1.5, NECK TO SAC RATIO 1.5/4. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15117544

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR MICROCATHETER